Kornimate/medical-research-clean huggingface dataset:
effectiveness of a new anti-hiv drug (ag1549) plus viracept (nelfinavir) plus combivir (zidovudine/lamivudine) in hiv-infected patients

Conditions: HIV Infections

Summary: the purpose of this study is to look at the effectiveness of giving a new anti-hiv drug (ag1549) plus viracept (nelfinavir) plus combivir (a tablet containing zidovudine plus lamivudine) to hiv-infected patients who are not taking anti-hiv drugs.

\[note: as of 2/28/2001, due to toxicity studies and concerns for safety, sites were notified that they need to discontinue patients from the capravirine/placebo arms and continue patients with their background therapies or switch patients to new therapies, as deemed appropriate by the investigators.\] patients are randomized to receive viracept plus combivir plus either ag1549 or placebo. patients remain on their assigned therapy for 48 weeks with one post-therapy follow-up visit. blood samples are taken regularly to quantify plasma hiv-1 rna, cd4 and cd8 counts, and peripheral blood mononuclear cells (pbmc). physical exams, safety assessments, and other tests are also done throughout the study. a blood sample is taken at baseline (pre-dose) for a pharmacokinetics assessment. on day 8 and at the end of weeks 4, 8, 16, 24, 36, and 48, pharmacokinetic sampling is done prior to dosing and between 2 to 4 hours post-dose.

Eligibility criteria:
inclusion criteria patients may be eligible if they: * are hiv-positive. * are at least 18 years old. * have a cd4 cell count of more than 50 cells/mm3. * have an hiv level of more than 5000 copies/ml. exclusion criteria patients will not be eligible if they: * have ever taken any of the following anti-hiv drugs: nonnucleoside reverse transcriptase inhibitors (nnrtis), ag1549, viracept, zidovudine, lamivudine, or combivir. other anti-hiv drugs are allowed only if taken for no more than 30 days with the last dose taken more than 6 months prior to study entry. * have taken an experimental drug within 28 days of study entry.

Keywords: drug therapy, combination zidovudine hiv protease inhibitors lamivudine disease progression reverse transcriptase inhibitors anti-hiv agents viral load nelfinavir combivir
comparison of hemodynamic stability and pain control

Conditions: Percutaneous Nephrolithotomy

Summary: this study was designed to evaluate whether patient position (lateral vs. prone) has affect on the need for analgesia and onset of pain after surgery.

percutaneous nephrolithotomy is the preferred surgical treatment in many cases of kidney stones which is performed in different positions such as prone, lateral, and supine. however, we do not have enough evidence comparing prone and lateral positioning regarding the need for analgesia and onset of pain after surgery. this study was designed to evaluate whether patient position (lateral vs. prone) has affect on the need for analgesia and onset of pain after surgery.

Eligibility criteria:
inclusion criteria: * inclusion criteria were age between 18-65 years, * having kidney stones; consent for spinal anesthesia, * asa classes (american society of anesthesiologists class) of 1 and 2 (patients without any cardiovascular or respiratory disorders) * superior and median ureter larger than 20 mm in diameter. exclusion criteria: * those with coagulation defects, * severe pain requiring more than one dose of fentanyl, * considerable rise of blood pressure or heart rate during the operation.

Keywords: percutaneous nephrolithotomy analgesic hemodynamic status
comparative pk study of econazole nitrate foam and econazole nitrate cream in subjects with interdigital tinea pedis aged 12 years to less than 18 years

Conditions: Interdigital Tinea Pedis

Summary: to compare the pharmacokinetics of econazole nitrate foam with econazole nitrate cream in subjects with interdigital tinea pedis aged 12 years to less than 18 years.

based on the results of a previous clinical study evaluating the pharmacokinetics, safety and efficacy of en foam versus the reference listed econazole nitrate cream and the foam vehicle in adults, the current clinical study is being conducted to provide additional pharmacokinetic data for en in the foam formulation in subjects ages 12 to less than 18 years with interdigital tinea pedis to support a clinical bridge for systemic safety to the rld in this pediatric population. the study also includes clinical and safety endpoints.

Eligibility criteria:
inclusion criteria: * be between 12 years and less than 18 years of age and of either sex. * have a clinical diagnosis of interdigital tinea pedis * parent/guardian has provided written informed consent and the subject has provided written assent. * be willing and able to use the assigned study medication as directed and to commit to all follow-up visits for the duration of the study. * have microscopic evidence (positive koh) of the presence of fungi and a positive fungal culture. * be in good health and free of any disease or physical condition which might, in the investigator's opinion, expose the subject to an unacceptable risk by study participation. * females must be non-pregnant, non-lactating and not intending to become pregnant during the course of the study. exclusion criteria: * is pregnant, nursing or planning a pregnancy during the study * has used topical antifungals or topical corticosteroids on the feet within 14 days prior to the start of the study. * has received systemic antifungal therapy within 12 weeks prior to the start of the study medication. * has used systemic antibacterials or systemic corticosteroids within 14 days prior to the start of the study. * has a history of uncontrolled diabetes mellitus or is immunocompromised (due to disease, e.g., hiv, or medications). * has concurrent moccasin-type tinea pedis (in the opinion of the investigator). * has any other skin disease which might interfere with the evaluation of tinea pedis. * is currently enrolled in an investigational drug or device study. * has received an investigational drug or treatment with an investigational device within 30 days prior to entering this study. * is unreliable, including subjects with a history of drug or alcohol abuse. * has known hypersensitivity to any of the components of the study medications.
long - term respiratory rehabilitation programs in chronic obstructive pulmonary disease.

Conditions: Chronic Obstructive Pulmonary Disease

Summary: objective: to determine whether a long-term maintenance program after respiratory rehabilitation, in contrast to the usual minimal maintenance therapy, improves the cost-effectiveness through: a.- maintaining long term effects in terms of effort capacity, hrql, and reduced exacerbations b.- reducing the total cost of care to patients, largely through reduction of exacerbations. material and methods: multi-center (4 hospitals) prospective randomized controlled study that will include 150 patients with moderate-severe copd (age \<75; bode 4-10) with a 3 years follow-up. all patients will receive an initial in-hospital rehabilitation program which includes: education, physiotherapy, lower and upper extremities training and respiratory muscles training. following completion of this program, patients will undergo concealed randomization to one of two maintenance strategies:1.-an intensive maintenance program (gr1) 2.- a standard, minimal monitoring program (gr2). on the intensive maintenance program (gr1) the physiotherapist will call once a week as a reminder and the patient will attend the hospital once a week . a physiotherapist will supervise the weekly in-hospital exercise and he/she will check if the patient is properly undergoing the rehabilitation treatment. outcomes: 1.- clinical: dyspnea (area of crq questionnaire), hrql (crq, sf 36); effort capacity (6minute walking test), bode index; 2.- economical: direct costs (programs); indirect costs (exacerbations, admissions); comparison of gr1 and gr2 costs; expected outcomes: reduction of dyspnea, improvement of hrql, effort capacity and bode index, and reduction of health expenditures in gr1 compared to gr2.


Eligibility criteria:
inclusion criteria: * copd patients * less than 77 years * bode index of 3-10 (bode 3 when fev1\<50% v. ref.). * clinically stable (at least one month) * informed consent signed exclusion criteria: * bone or muscle disease that limits the exercise training. * heart disease that disable physic exercise. * bronchiectasis or other respiratory diseases different than copd. * comorbidity that difficult o disable respiratory rehabilitation program carrying out. * life expectation less than 2 years.

Keywords: copd pulmonary rehabilitation
mirikizumab and tirzepatide administered in adult participants with moderately to severely active crohn's disease and obesity or overweight

Conditions: Crohn's Disease; Obesity or Overweight

Summary: the main purpose of this study is to evaluate the efficacy and safety of mirikizumab and placebo compared with mirikizumab and concomitantly administered tirzepatide in adult participants with moderately to severely active cd and obesity, or overweight. the maximum duration of this study is up to 61 weeks.


Eligibility criteria:
inclusion criteria: * have had a diagnosis of crohn's disease (cd) or perianal fistulizing cd established at least 3 months prior to enrollment confirmed by clinical, endoscopic, and histological criteria. * have obesity body mass index 30 kilograms per meter squared (bmi ≥30 kg/m2), or overweight (bmi ≥27 kg/m2 to \<30 kg/m2) and in the presence of at least 1 of these weight-related comorbid conditions: * hypertension * type 2 diabetes mellitus (t2dm) * dyslipidemia * obstructive sleep apnea, or * cardiovascular disease. * have moderately to severely active cd defined by a cdai score of at least 220 at baseline. * have a centrally read simple endoscopic score for crohn's disease (ses-cd) score ≥6 for patients with ileal-colonic or ≥4 for patients with isolated ileal disease within 21 days before the first dose of study treatment. * have a history of cd involving only or predominantly the colon for greater than or equal to 8 years with a surveillance colonoscopy within 1 year prior to baseline must have documented negative results for colorectal dysplasia and cancer. * have an inadequate response to, loss of response to, or intolerance to: * at least one conventional therapy (such as corticosteroids, oral azathioprine (aza) or 60-mercaptopurine (6-mp), or oral aminosalicylates (for example, mesalamine, sulfasalazine, olsalazine, balsalazide) and/or, * at least one advanced therapy for cd (defined as: a biologic or biosimilar medication such as anti-tumor necrosis factor (tnf) antibodies, anti-integrin antibodies, janus kinase (jak) inhibitors such as upadacitinib, or anti-interleukin (il)-12p40 antibodies, for example, ustekinumab). exclusion criteria: * have a current diagnosis of ulcerative colitis (uc), inflammatory bowel disease-unclassified (formerly known as indeterminate colitis), or primary sclerosing cholangitis. * have more than 2 missing segments of the following 5 segments: terminal ileum, ·right colon, transverse colon, ·left colon, and rectum. * currently have or are suspected to have an abscess. * have a stoma, ileoanal pouch, or ostomy. * have a history of more than 3 small bowel resections, diagnosis of short bowel syndrome, or any intestinal or non-intestinal intra-abdominal surgery within 3 months of baseline. * have a diagnosis of type 1 diabetes mellitus (t1dm) or have insulin-treated t2dm. * have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening. * have had more than 5% body weight change in the past 3 months * have a current or recent acute, active infection.
mastering hospital antimicrobial resistance and its spread into the community

Conditions: ESBL Infection; Methicillin-Resistant Staphylococcus Aureus

Summary: data on occurrence of antimicrobial resistant bacteria acquisition in rehabilitation centers will be collected. after removal of patient identifiers, information regarding the patients population will be entered into electronic sheet. the phase will last twelve months in each center.

all patients admitted to the department will be examined on admission, two weeks latter and monthly by obtaining nares and perirectal cultures. these cultures will be processed for detection the target organisms. this activity is part of the good medical practice and is performed on routine basis in various hospital units epidemiological data will be collected from patient records. this data will be stored after removal of all patients' identifiers. these data will be transferred for analysis to tel aviv medical center

Eligibility criteria:
inclusion criteria: * hospitalized patients are older then 18 years old exclusion criteria: * age 18 years or less

Keywords: to define activities and patient characteristics likely to lead to dissemination of resistant bacteria in rehabilitation centers and to define specific risk factors for acquisition of resistant bacteria (esbl producers and mrsa) in rehabilitation centers. esbl producers mrsa
clinical characteristics and outcome of patients with community acquired pneumonia

Conditions: Community Acquired Pneumonia (CAP)

Summary: the goal of this observational study is to evaluate the clinical characteristic and outcomes of patients with community-acquired pneumonia admitted to sohag university hospital. the researcher will take medical history and clinical examination and investigations of participants . the participants will visit the clinic after one month to be reevaluated again .

community acquired pneumonia is acute infection of the pulmonary parenchyma that occurs in the community in a patient who has not been hospitalized within 14 days prior to onset of symptoms or hospitalized less than 2 days prior to the onset of symptoms the aim of the study typically focuses on examining the various factors that influence the presentation, management, and outcomes of individuals diagnosed with pneumonia that is acquired outside of a hospital or healthcare setting. type of the study: observational study outcomes of interest include: i. mortality (in hospital and 30 days). ii. the need for further mechanical ventilation or icu admission. iii. duration of hospital stay.

Eligibility criteria:
inclusion criteria: * the study will include patients ≥18 years old with community acquired pneumonia exclusion criteria: 1. patients already was diagnosed as active malignancy before admission 2. patient on chemotherapy 3. hiv patients 4. indication of mechanical ventilation on admission

Keywords: cap pneumonia clinical characteristics
martial arts therapy in autism spectrum disorders

Conditions: Autism Spectrum Disorders

Summary: the purpose of the present study was to determine whether teaching karate techniques training leads to reduction in communication deficit of children with autism spectrum disorders.


Eligibility criteria:
inclusion criteria: * individuals diagnosed as autism spectrum disorders according to the diagnostic and statistical manual of mental disorders-fourth edition, text revision. * age range in 5 to 16. exclusion criteria: * not participating in up to 3 intervention sessions.
internet-cbt for insomnia

Conditions: Insomnia; Depression

Summary: this study includes two sub-trials. in trial 1 patients suffering from insomnia but not meeting the criteria for depression are randomised to either therapist guided internet-based cbt for insomnia or to a control group with a non-guided, brief self-help program that acts as a placebo control. the primary purpose is to evaluate reduction in insomnia severity (compared to placebo) after treatment and at follow-ups at 6-month, 1 year and 3 years. secondary purpose is to evaluate the costeffectiveness of the treatment and to evaluate if the insomnia treatment has a preventive effect on future depressive episodes. recruitment is done through mass media and includes all regions of sweden. initial assessment based on questionnaires and telephone interviews. trial 2 includes patients suffering from both insomnia and depression. randomization is done between either cbt for insomnia or cbt for depression (both internet-based) to evaluate each respective treatment's effect on both insomnia and depression. the patients need for further treatment after the initial one will be measured and used as a secondary outcome. recruitment is done through mass media but only citizens in the stockholm area are included since the initial assessment are based on both questionnaires and telephone interviews as well as a visit at a psychiatrist located at the internet psychiatry clinic in stockholm. both trials will include health economic data and analysis. for the longer follow-up periods (1 and 3 years), registers will be used to analyse consumption of sleep medication and antidepressants as well as general health care utilization.


Eligibility criteria:
inclusion criteria: * clinical level of insomnia (more than 10 on isi) * meets criteria for insomnia according to dsm-iv-tr * enough language skills * only trial 2: meets criteria for major depressive disorder according to dsm-iv-tr exclusion criteria: * sleep disorders requiring other treatment * high consumption of alcohol/drugs that affect sleep * started to use or changed the dose of antidepressant drug during the last 2 months * somatic or psychiatric conditions requiring acute care * working night shifts * only trial 1: meets criteria for major depressive disorder according to dsm-iv-tr

Keywords: self-help treatment internet treatment cbt prevention comorbidity
a study to evaluate the safety and efficacy of ombitasvir/paritaprevir/r with or without dasabuvir and with or without ribavirin in chronic hepatitis c virus genotype 1 or 4 infected adults with successfully treated early stage hepatocellular carcinoma

Conditions: Chronic Hepatitis C Infection

Summary: the purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir (obv/ptv/r), with or without dasabuvir (dsv) coadministered with or without ribavirin (rbv) for 12 or 24 weeks in adult patients with genotype 1 or genotype 4 chronic hcv infection and treated early stage hepatocellular carcinoma with compensated cirrhosis.


Eligibility criteria:
inclusion criteria: 1. male or female, at least 18 years of age at time of screening 2. chronic hepatitis c virus (hcv) infection prior to study enrollment with screening laboratory results indicating hcv genotype 1 or 4 infection 3. early stage hepatocellular carcinoma (hcc) diagnosed based on the typical hallmark of hcc (hypervascular in the arterial phase with washout in the portal venous or delayed phases) 4. compensated cirrhosis defined as a child-pugh score of 5 or 6 at screening • a minimal rim of ascites if detected at imaging is acceptable. exclude ascites that requires the need to apply diuretic treatment to control ascites 5. documented complete response to hcc treatment. 6. females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control. exclusion criteria: 1. use of known strong or moderate inducers of cytochrome p450 3a (cyp3a) in participants receiving ombitasvir/paritaprevir/ritonavir (obv/ptv/r) with and without dasabuvir (dsv), strong inducers and inhibitors (e.g., gemfibrozil) of cytochrome p450 2c8 (cyp2c8) in participants receiving obv/ptv/r with dsv, medications contraindicated for ritonavir or rbv (for those that receive rbv) within 2 weeks or 10 half-lives (if known), whichever is longer, prior to study drug . for medications contraindicated with abbvie's 2-direct-acting antiviral agent (2-daa) and 3-daa regimen, refer to the recommended prescribing information section of the approved local product labels. 2. positive test result for hepatitis b surface antigen (hbsag) or anti-human immunodeficiency virus antibody (hiv ab). 3. patients regardless of eligibility to liver transplant, who have a comorbid disease that might preclude completion of study follow-up. 4. clinically significant abnormalities, other than hcv infection, in a participant with hcc based upon the medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ecg) that make the participant an unsuitable candidate for this study in the opinion of the investigator.

Keywords: chronic hepatitis c infection early stage hepatocellular carcinoma
evaluate azvudine in preventing sars-cov-2 infection in household contacts of covid-19 in china

Conditions: COVID-19

Summary: a phase ii randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of azvudine in preventing sars-cov-2 infection in household contacts of individuals infected with sars-cov-2 in china

a multicentre, randomized, double-blind, placebo-controlled phase ii clinical study to evaluate the efficacy and safety of azvudine versus placebo in preventing sars-cov-2 infection in household contacts with sars-cov-2 infection individuals.approximately 300 adults with household contact exposure to individuals with a confirmed sars-cov-2 infection will be enrolled.

Eligibility criteria:
inclusion criteria: 1、18-65 years old at the signing of informed consent. 2、household contacts of individual with symptomatic covid-19. symptomatic covid-19 cases (index case) to be identified as those symptomatic and recently tested (rapid antigen test or rt-pcr) positive for sars-cov-2 and must fulfill the following criteria 1) collection of the first positive sars-cov-2 test sample less than 24 hours before randomization, 2) have at least one symptom attributable to covid-19. 3、rt-pcr test negative (with nasopharyngeal \[np\] swab samples) or rapid antigen test negative at the time of screening and without any suspicious covid-19 symptoms within 2 weeks before randomization. 4、subject expects to be living in the same household with the symptomatic covid-19 cases during the whole study period. exclusion criteria: 1. subject with a history of sars-cov-2 vaccinations within 1 months before randomization. 2. subject with a history of sars-cov-2 infection within 6 months before randomization. 3. with any serious infection requiring systemic anti-infective therapy within 14 days before randomization. 4. allergic to the investigational agent or any components of the formulation. pregnant or breast-feeding women. 5. women of childbearing potential who are unwilling to practice highly effective contraception during the study, and for at least 6 months after the study; sexually active men who are unwilling to use medically acceptable birth control during the study period. 6. have other conditions not suitable for inclusion as judged by the investigator.
diagnostic study of biomarkers in bal of icu patients with lung infiltrates

Conditions: INvasive Aspergillosis; Mechanical Ventilation; Lung Infiltrates; Diagnostics; Biomarker

Summary: the aim of this project is therefore to explore on the clinical significance of analyzing surrogate markers combined with conventional diagnostics in the icu setting. bal, blood and biopsy samples will be subjected to a combined analysis of gm, bdg, aspergillus specific pcr assays in addition to conventional diagnostics (microscopy, culture,histology) for icu pts with pulmonary infiltrates. as gm and bdg are not species-specific, three established and repeatedly published species specific pcr-based assays (nested pcr, real time pcr assay, multifungal dna array)developed by our group will be investigated in combination with the serological tests in a multicenter prospective clinical diagnostic trial.


Eligibility criteria:
inclusion criteria: * underlying conditions (see above) * being on mechanical ventilation * lung infiltrates exclusion criteria: * immunocompetent patients (not fulfilling the criteria above)